Registration Dossier
Registration Dossier
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EC number: 220-635-9 | CAS number: 2840-28-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study, but non GLP and no purity of test item available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-amino-4-chlorobenzoic acid
- EC Number:
- 220-635-9
- EC Name:
- 3-amino-4-chlorobenzoic acid
- Cas Number:
- 2840-28-0
- Molecular formula:
- C7H6ClNO2
- IUPAC Name:
- 3-amino-4-chlorobenzoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own premises
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one site of the back shaved, the other site shaved and abraded
- Vehicle:
- other: Polyehtylen glycol + 0.9% saline (70:30 parts)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24, 48, 72 hours and 4 and 7 days
- Number of animals:
- 3 male and 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm flank
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin
Any other information on results incl. tables
Table 1: Detailed Scores:
|
|
24 hours |
48 hours |
72 hours |
4 days |
7 days |
|||||||||||||||||||||||||
Sex |
|
male |
female |
male |
female |
male |
female |
male |
male |
male |
female |
||||||||||||||||||||
Animal # |
|
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
Erythema |
a |
2 |
2 |
1 |
2 |
2 |
2 |
1 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
b |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
1 |
1 |
2 |
2 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
a |
1 |
2 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
b |
1 |
2 |
2 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
a: intact skin
b: abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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